COVID-19CovidSurg-CanNCT04384926
Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis
An observational study of COVID-19 and Coronavirus, run by University of Birmingham at 1 site in Spain.
Trial summary
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus, Cancer
- What is being tested?
- Elective Cancer Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients planned for curative cancer surgery that have surgery completed during the COVID-19 pandemic * Patients planned for curative cancer surgery that have surgery delayed or cancelled during the COVID-19 pandemic
Who may be able to join
- Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
- Decision made for surgical management with a curative intent
Who cannot join
- Surgery planned with non-curative intent
- Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Henares
Madrid
Ana Minaya-Bravo
Ana Minaya-Bravo
About this study
Official title: Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.
Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of:
- Colorectal cancer
- Oesophagogastric cancer
As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.
Read the detailed description
The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care.
We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown.
High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).
The primary aim is to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.
Secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop COVID-19 infection versus those who do not; an exploration of the scale of resource constraints related to the COVID-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the COVID-19 pandemic; to evaluate the impact of the COVID-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent.
This investigator-led, non-commercial, non-interventional study is extremely low to zero risk. This study does not collect any patient identifiable information and data will not be analysed at hospital-level.
- Conditions
- COVID-19, Coronavirus, Cancer, Surgery
- Being tested
- Elective Cancer Surgery
- Keywords
- Elective, Cancer Surgery
- Medical subject headings
- COVID-19, Coronavirus Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Cancer SurgeryProcedure or surgery
Planned, curative cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic Receives: Procedure: Elective Cancer Surgery | |
| Cohort 2 | Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery delayed or cancelled during the COVID-19 pandemic Receives: Procedure: Elective Cancer Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative COVID-19 infection rate
Frequency of COVID-19 infection within 30 days
Measured: 30 days
Secondary outcomes (4)
30-day postoperative mortality rate
Number of deaths at 30-days post surgery
Measured: 30-days
Postoperative critical care utilisation rate in high-risk cancer surgery patients.
Critical care utilisation in high-risk cancer surgery patients
Measured: 30-days
Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery
Number of patients with a delay of more than 4 weeks from the decision taken for surgery to the date of surgery
Measured: More than 4 weeks from decision date
Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery
Number of non-operated patients with progression to incurable disease by 3-months after decision for surgery
Measured: Up to 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start30 Mar 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneel Bhangu, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384926
- Sponsor's protocol ID
- CSC-20200324
- Acronym
- CovidSurg-Can
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to other researchers
Publications
NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.
PubMed 38906616COVIDSurg Collaborative. Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1507-1517. doi: 10.1016/S1470-2045(21)00493-9. Epub 2021 Oct 5.
PubMed 34624250Glasbey JC, Nepogodiev D, Simoes JFF, Omar O, Li E, Venn ML, Pgdme, Abou Chaar MK, Capizzi V, Chaudhry D, Desai A, Edwards JG, Evans JP, Fiore M, Videria JF, Ford SJ, Ganly I, Griffiths EA, Gujjuri RR, Kolias AG, Kaafarani HMA, Minaya-Bravo A, McKay SC, Mohan HM, Roberts KJ, San Miguel-Mendez C, Pockney P, Shaw R, Smart NJ, Stewart GD, Sundar Mrcog S, Vidya R, Bhangu AA; COVIDSurg Collaborative. Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study. J Clin Oncol. 2021 Jan 1;39(1):66-78. doi: 10.1200/JCO.20.01933. Epub 2020 Oct 6.
PubMed 33021869
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)
- ClinicalTrials.gov ID
- NCT04384926
- Acronym / sponsor ID
- CovidSurg-Can / CSC-20200324
- Conditions
- COVID-19, Coronavirus, Cancer, Surgery
- Keywords
- Elective, Cancer Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.
Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of:
- Colorectal cancer
- Oesophagogastric cancer
As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.
Detailed description
The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care.
We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown.
High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).
The primary aim is to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.
Secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop COVID-19 infection versus those who do not; an exploration of the scale of resource constraints related to the COVID-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the COVID-19 pandemic; to evaluate the impact of the COVID-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent.
This investigator-led, non-commercial, non-interventional study is extremely low to zero risk. This study does not collect any patient identifiable information and data will not be analysed at hospital-level.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: Elective Cancer SurgeryAdult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic |
| Cohort 2 | – | Procedure: Elective Cancer SurgeryAdult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery delayed or cancelled during the COVID-19 pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients planned for curative cancer surgery that have surgery completed during the COVID-19 pandemic * Patients planned for curative cancer surgery that have surgery delayed or cancelled during the COVID-19 pandemic
Key inclusion criteria (2 listed)
- Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
- Decision made for surgical management with a curative intent
Key exclusion criteria (2 listed)
- Surgery planned with non-curative intent
- Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective Cancer SurgeryPlanned, curative cancer surgery | Procedure or surgery | Cohort 1, Cohort 2 |
Primary outcome
30-day postoperative COVID-19 infection rate
Time frame: 30 days
Frequency of COVID-19 infection within 30 days
4 secondary outcomes
30-day postoperative mortality rate
Time frame: 30-days
Postoperative critical care utilisation rate in high-risk cancer surgery patients.
Time frame: 30-days
Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery
Time frame: More than 4 weeks from decision date
Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery
Time frame: Up to 3-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 38906616NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.
- Derived from this study: PubMed 34624250COVIDSurg Collaborative. Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1507-1517. doi: 10.1016/S1470-2045(21)00493-9. Epub 2021 Oct 5.
- Derived from this study: PubMed 33021869Glasbey JC, Nepogodiev D, Simoes JFF, Omar O, Li E, Venn ML, Pgdme, Abou Chaar MK, Capizzi V, Chaudhry D, Desai A, Edwards JG, Evans JP, Fiore M, Videria JF, Ford SJ, Ganly I, Griffiths EA, Gujjuri RR, Kolias AG, Kaafarani HMA, Minaya-Bravo A, McKay SC, Mohan HM, Roberts KJ, San Miguel-Mendez C, Pockney P, Shaw R, Smart NJ, Stewart GD, Sundar Mrcog S, Vidya R, Bhangu AA; COVIDSurg Collaborative. Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study. J Clin Oncol. 2021 Jan 1;39(1):66-78. doi: 10.1200/JCO.20.01933. Epub 2020 Oct 6.
- Individual participant dataSharing planned: No. No individual participant data will be made available to other researchers
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aneel Bhangu principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus, run by University of Birmingham at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneel Bhangu (+44 1216272949, A.A.Bhangu@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative COVID-19 infection rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04384926, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.